Major procedure-related complications in a real-world cohort of patients undergoing transvenous lead extraction

M. Doring, J. Lucas, K. Bode, S. Nedios, S. Hilbert, M. Ebert, C. Moscoso Ludueña, G. Hindricks, S. Richter
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Abstract

Type of funding sources: None. Transvenous lead extraction (TLE) is the mainstay therapy for device-related infections. Though TLE procedures are associated with low complication and high success rates, risk factors for major procedure-related complications remain not well defined. To evaluate the safety and efficacy of TLE in a large single centre cohort and to identify risk factors for major complications. All consecutive patients undergoing TLE in our department between May 2012 and December 2021 were included in a prospective registry. Our protocol for TLE followed a stepwise approach according to lead dwell time and estimated complexity of the procedure: use of simple traction ± locking stylet (LS) ± mechanical and/or powered sheaths ± snare technique via a femoral or jugular access. Patient characteristics, procedural data and complications were gathered and analysed. Logistic regression analysis was applied to identify risk factors for major procedure related complications. A total of 2218 leads (25.7% ICD leads) were targeted for TLE in 1060 patients (67.7 ± 14.8 years; 74% male). The mean lead dwell time was 82 ± 62 months. The leading indication for TLE was cardiac device related infection (CDRI) in 695 patients (65.6%), 373 (35.2%) had systemic and 322 (30.4%) localized infection. Leads were extracted by simple traction in 30%, traction with LS in 3.7%, dilator sheaths with LS in 47.7%, and additional use of powered mechanical sheaths in 14.6%. The snare technique was used in 3.9%, with additional venous entry from femoral in 3.5% and jugular in 1.0% of all targeted leads. TLE was completely successful in 92.6%, partially successful with lead fragments <4cm in 4.2%, and failed in 3.1% of all patients, which translated to a clinical success rate of 96.9%. Twenty-nine patients (2.7%) experienced minor and 18 patients (1.7%) had major procedure-related complications (cardiac tamponade/perforation) including 2 intraprocedural deaths (0.2%). Presence of abandoned leads (HR 8.41, 95% CI 3.21–22.02; p<0.001), lead-years-per-patient (HR 1.063, 95% CI 1.037–1.090; p<0.001), dwelling time of the oldest lead (HR 1.011, 95% CI 1.006–1.016; p<0.001), and a right-sided implantation (HR 2.68, 95% CI 1.05–6.83; p=0.04) were significant predictors of major complications in logistic regression analysis. TLE is feasible, effective and safe in our large single centre experience. Overall complication and failure rates are low. Following our TLE protocol, the presence of abandoned leads, a right-sided implantation and dwelling time of the extracted leads were associated with major procedure-related complications.
主要的手术相关的并发症在现实世界的队列患者接受经静脉铅提取
资金来源类型:无。经静脉铅提取(TLE)是器械相关感染的主要治疗方法。虽然TLE手术并发症少,成功率高,但主要手术相关并发症的危险因素尚未明确。在大型单中心队列中评估TLE的安全性和有效性,并确定主要并发症的危险因素。2012年5月至2021年12月在我科连续接受TLE治疗的所有患者纳入前瞻性登记。我们的TLE方案是根据导联停留时间和估计的程序复杂性采用逐步方法:使用简单牵引±锁定针(LS)±机械和/或动力护套±通过股动脉或颈静脉通道的圈套技术。收集和分析患者特征、手术资料和并发症。应用Logistic回归分析确定主要手术相关并发症的危险因素。1060例患者(67.7±14.8岁;74%的男性)。平均导联停留时间为82±62个月。695例(65.6%)患者的主要适应症是心脏装置相关感染(CDRI), 373例(35.2%)为全身性感染,322例(30.4%)为局部感染。单纯牵引拔铅占30%,LS牵引拔铅占3.7%,LS扩张器套拔铅占47.7%,另外使用动力机械套拔铅占14.6%。圈套技术占3.9%,从股静脉进入的占3.5%,从颈静脉进入的占1.0%。92.6%的患者完全成功,4.2%的患者铅片<4cm部分成功,3.1%的患者失败,临床成功率为96.9%。29例患者(2.7%)出现轻微并发症,18例患者(1.7%)出现主要手术相关并发症(心脏填塞/穿孔),包括2例术中死亡(0.2%)。存在废弃导联(HR 8.41, 95% CI 3.21-22.02;p<0.001),每位患者的lead-years (HR 1.063, 95% CI 1.037-1.090;p<0.001),最老导联停留时间(HR 1.011, 95% CI 1.006-1.016;p<0.001),右侧植入(HR 2.68, 95% CI 1.05-6.83;P =0.04)是logistic回归分析中主要并发症的显著预测因子。在我们的大型单中心经验中,TLE是可行、有效和安全的。总的并发症和失败率很低。根据我们的TLE方案,遗留导联、右侧植入以及拔出导联的停留时间与主要的手术相关并发症有关。
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